Project Summary NIH SBIR Phase-II, Jan 5, 2017 Application Title: ?A disposable assay for the monitoring of heart failure at the point-of-care? Accel Diagnostics, LLC Contact PI: Alberto Gandini, Ph.D., MBA The objective of this proposed SBIR Phase II is to complete the development and optimization of the pScreen-BNP? platform for the monitoring of Heart Failure, HF, in home patients. The proposed activities include integration of a smart phone app, scale up manufacturing capability that adhere to the FDA Quality Control guidelines, reduce production cost, and complete a clinical validation study in collaboration with The University of California San Francisco. The pScreen-BNP has several unique features. It is fully disposable (single use) and does not requires bench-top or hand-held devices, hence it is easy to use and very affordable; it is also a quantitative and sensitive assay, hence it provides an accurate and precise quantification of the level of Brain Natriuretic Peptide (BNP) in HF patients' blood. BNP is a cardiac biomarker elaborated by heart tissue when stressed due to the onset of heart failure. It is widely known for its specificity and sensitivity in the diagnosis of HF. Heart Failure remains a leading cause of death and disability in elderly Americans, and places a significant burden on the healthcare systems with a cost exceeding $40 billion/year. Early diagnosis is a critical necessity to achieve meaningful change in outcome. pScreen-BNP? marks in this respect, a paradigm shift in HF management. It allows, for the first time, HF patients to frequently monitor their level of heart distress outside of the clinical setting, e.g. in the comfort of their homes, similar to the more familiar glucose test. Our solution would enables patients and their physicians to respond before physical symptoms occur, preventing otherwise frequent life threatening events and costly re- hospitalizations. pScreen-BNP? is based on a patent-protected technology initially developed at Carnegie Mellon University, and licensed exclusively Worldwide to Accel Diagnostics.